Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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The vitrax ii product is being recalled because during routine stability testing it was discovered that a sample tested at the three month time point had a ph value of 7.70 which exceeded the ph specification range of 6.8 to 7.5 resulting in a lab investigation. the investigation revealed that some units from different lots post eto sterilization have a ph greater than the upper ph limit of 7.5. the highest value was found to be 8.29.